| 简介：
部份中文雷贝拉唑钠处方资料（仅供参考）
英文名：Rabeprazole Sodium
商品名：Rabeprazole Sodium Tab
中文名：雷贝拉唑钠片
生产商：科研制药
药品简介
Rabeprazole Sodium（ラベプラゾールナトリウム，雷贝拉唑）是一种氢离子帮浦阻断。其作用持久，“胃酸分泌”作用低。 消化性溃疡或反流性食管炎和其他胃酸过多引起的疾病的其他治疗。
ラベプラゾールナトリウム錠10mg「科研」
药效分类名称
质子泵抑制剂
批准日期：2010年11月
商標名
Rabeprazole Sodium Tab
一般名
ラベプラゾールナトリウム（Rabeprazole Sodium）
化学名
Monosodium (RS)-2-({[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methyl}sulfinyl)-1H-benzimidazolide
分子式
C18H20N3NaO3S
分子量
381.42
構造式
性状
它是一种白色至微黄白色粉末。
极易溶于水，溶于乙醇（99.5）。
溶于0.01 mol/L氢氧化钠TS。
本品具有吸湿性。
该产品的水溶液（1→20）不显示旋光。
本品具有结晶多晶现象。
处理注意事项
稳定性测试
使用最终包装产品进行长期储存试验（25℃，60%RH，3年），外观、溶出行为、含量等均在标准范围内，雷贝拉唑钠片10mg “Kaken”在市场上正常发行，以下已确认稳定3年。
药效药理
它是一种质子泵抑制剂。 在酸分泌细胞的酸性区域成为活性物质（次磺酰胺形式），修饰质子泵的SH基团（H+、K+-ATPase），抑制酶活性，抑制酸分泌。
适应症
小剂量阿司匹林给药后抑制胃溃疡、十二指肠溃疡、吻合口溃疡、反流性食管炎、佐林格-埃利森综合征、非糜烂性胃食管反流病、胃溃疡或十二指肠溃疡的复发。
协助根除以下幽门螺杆菌
胃溃疡、十二指肠溃疡、胃MALT淋巴瘤、特发性血小板减少性紫癜、早期胃癌内镜治疗后的胃、幽门螺杆菌感染的胃炎
用法与用量
· 胃溃疡、十二指肠溃疡、吻合口溃疡、Zollinger-Ellison综合征
一般来说，对于成人，雷贝拉唑钠10毫克每天口服一次，但根据病情，雷贝拉唑钠20mg也可以每天口服一次。胃溃疡和吻合口溃疡常用剂量最长可达8周，十二指肠溃疡最长可达6周。
· 返流性食管炎
<治疗>
治疗反流性食管炎时，雷贝拉唑钠成人常用剂量为10毫克，每日1次口服，但根据病情，20毫克也可每日1次口服。此外，它通常给药长达8周。如果质子泵抑制剂治疗不充分，可一次口服 10毫克或20毫克，每天两次，再服用 8周。然而，每天两次给予20毫克仅限于严重粘膜损伤的病例。
<维持疗法>
在反复复发和复发的反流性食管炎的维持治疗中，通常的成人剂量是每天一次口服雷贝拉唑钠10毫克。此外，在质子泵抑制剂治疗不充分的反流性食管炎的维持治疗中，可以口服10毫克，每天2次。
· 非糜烂性胃食管反流病
通常的成人剂量是每天一次口服10毫克雷贝拉唑钠。此外，它通常给药长达4周。
· 服用低剂量阿司匹林时抑制胃溃疡或十二指肠溃疡的复发
一般成人口服雷贝拉唑钠5mg，每日1次，但若效果不足，可口服雷贝拉唑钠10毫克，每日1次。
· 协助根除幽门螺杆菌
成人常用剂量为雷贝拉唑钠10毫克、水合物阿莫西林750毫克（滴度）和克拉霉素200毫克（滴度），每天口服两次，连续7天。
克拉霉素的剂量可根据需要适当增加。但是，上限为每天两次400毫克（滴度）。
如果质子泵抑制剂、水合物阿莫西林和克拉霉素三联治疗幽门螺杆菌根除治疗不成功，替代治疗通常是成人雷贝拉唑钠10毫克一次，阿莫西林750毫克（滴度）水合物和250毫克三剂。每天两次同时口服甲硝唑毫克，共7天。
包装
片
(PTP) 100錠
(PTP) 140錠
(PTP) 500錠
(バラ) 100錠
制造商和分销商
大东制药株式会社
销售
科研製薬株式会社
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/2329028F1201_1_16/
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RABEPRAZOLE Sodium Tablets 10mg "KAKEN"（ラベプラゾールナトリウム錠10mg「科研」）
Brand name : RABEPRAZOLE Sodium Tablets 10mg "KAKEN"
Active ingredient: Sodium rabeprazole
Dosage form: pale yellow tablet, diameter: 6.7mm, thickness: 3.3mm
Print on wrapping: ラベプラゾールナトリウム錠10mg「科研」, RABEPRAZOLE SODIUM Tab.10mg 「KAKEN」, 10mg, KC80
Effects of this medicine
This medicine inhibits the mechanism of gastric acid secretion in gastric mucosal cells to suppress gastric acid secretion. It consequently results in rapid healing of gastric and duodenal ulcer, and relieves pain and heartburn attributed to reflux esophagitis.
It is usually used in the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis, and non-erosive gastroesophageal reflux disease. It is also used for adjunctive medicine to eradicate Helicobacter pylori bacteria in the stomach in gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, and after endoscopic therapy for early gastric cancer, and Helicobacter pylori gastritis with other antibacterial medicines.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have liver problems.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•For gastric ulcer and duodenal ulcer, anastomotic ulcer and Zollinger-Ellison syndrome: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once daily. However, the dosage may be increased up to 2 tablets (20 mg), once daily. Duration of taking the medicine is up to 8 weeks for gastric ulcer and anastomotic ulcer; 6 weeks for duodenal ulcer.
For reflux esophagitis: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once daily. However, the dosage may be increased up to 2 tablets (20 mg), once daily. Duration of taking the medicine is up to 8 weeks. When proton pump inhibitor treatment is ineffective, take 1 tablet (10 mg) or 2 tablets (20 mg) at a time, twice daily for further 8 weeks. However, a dose of 2 tablets (20 mg) at a time, twice daily is only used in patients with severe mucosa injury. For reflux esophagitis which relapses several times, take 1 tablet (10 mg), once daily.
For non-erosive gastroesophageal reflux disease: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, once daily. Duration of taking the medicine is up to 4 weeks.
For helping to eradicate Helicobacter pylori bacteria: In general, for adults, take 1 tablet (10 mg of the active ingredient) at a time, twice daily, for 7 days, concomitantly with amoxicillin hydrate and clarithromycin. If this treatment resulted in failure, take 1 tablet (10 mg) at a time, twice daily, for 7 days, concomitantly with amoxicillin hydrate and metronidazole.
In any case, strictly follow the instructions.
•Swallow the tablet without chewing or crushing.
•If you miss a dose, take a dose as soon as possible when you remember that you missed a dose. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash, hives, itching sensation, diarrhea, abdominal pain, abdominal bloating and constipation. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•breathing difficulty, hives, dizziness [shock, anaphylaxis]
•fever, anemia, gum bleeding, subcutaneous bleeding [pancytopenia, agranulocytosis, thrombocytopenia, hemolytic anemia]
•nausea, vomiting, decreased appetite, yellowing in the skin or white of the eye [fulminant hepatitis, hepatic dysfunction, jaundice]
•fever, widespread red rash, erosion in the eye, mouth or genitalia [toxic epidermal necrosis, Stevens-Johnson syndrome, erythema multiforme]
•decreased urine output, edema, fever [acute renal failure, interstitial nephritis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them.
Kaken Pharmacetical Co.,LtdInternal
Revised: 4/2016
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. |
